FDA recall Z-0564-2024

Product

VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

Reason for recall

Cassette did not meet an 1n-process flow criterion.

Distribution

US: AZ and FL

Key facts

Status

Ongoing

Initiation date

2023-11-17

Report date

2023-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2024